- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03445585
Biobank for Cholestatic Liver Diseases.
A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
Study Overview
Status
Detailed Description
This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).
Blood, saliva, stool, and urine samples will be collected periodically during patient visits or via a mail-home kit. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. Anticipated research will focus on multi-omics assessments of biospecimens to better define how these diseases start and progress in order to develop novel tests for early detection of complication and better disease prognostication.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erik Schlicht, CCRP, B.A.
- Phone Number: 507-284-4312
- Email: schlicht.erik@mayo.edu
Study Contact Backup
- Name: Jackie Bianchi
- Phone Number: 507-266-0346
- Email: bianchi.jackie@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55901
- Recruiting
- Mayo Clinic
-
Contact:
- Erik M Schlicht, CCRP
- Phone Number: 507-284-4312
- Email: schlicht.erik@mayo.edu
-
Principal Investigator:
- Konstantinos N Lazaridis, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
PSC
- Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.
- The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.
- Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
- Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
PBC
- Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.
- The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.
- Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
- Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
Controls
- Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.
Liver Disease Controls
- Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.
Exclusion Criteria (all subjects):
- PBC or PSC patients with known and overlapping other chronic liver diseases
- Patients unable to provide informed consent
- Prisoners and institutionalized individuals
Exclusion Criteria (for bile collection during ERCP)
- PSC with orthotopic liver transplantation
- History of Roux en Y
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Primary Sclerosing Cholangitis
Patients with a diagnosis of primary sclerosing cholangitis (PSC).
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Primary Biliary Cirrhosis/Cholangitis
Patients with a diagnosis of primary biliary cirrhosis (PBC).
|
Control group 1
Patients who do not have PBC or PSC but do have another form of chronic liver disease.
|
Control group 2
Patients without liver disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants in the study.
Time Frame: 20 years
|
Number of participants in the study.
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of samples collected (per type).
Time Frame: 20 years
|
Number of samples collected (blood, urine, stool, bile, bile duct cells)
|
20 years
|
Number of clinical phenotypes and/or endpoints observed (per category)
Time Frame: 20 years
|
Number of clinical phenotypes and/or endpoints observed (i.e.
disease progression, liver cancer development)
|
20 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Konstantinos Lazaridis, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Fibrosis
- Biliary Tract Diseases
- Bile Duct Diseases
- Cholestasis, Intrahepatic
- Cholestasis
- Liver Cirrhosis
- Liver Diseases
- Cholangiocarcinoma
- Cholangitis
- Cholangitis, Sclerosing
- Liver Cirrhosis, Biliary
Other Study ID Numbers
- 16-005892
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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